US FDA Allows Outsourcers To Compound Hydroxychloroquine As COVID-19 Drives Demand
Pharmacies Say More Additions Needed
Executive Summary
The US FDA has added hydroxychloroquine sulfate to the list of drugs outsourcing facilities can compound as pharmacy group calls for more such approvals with COVID-19 driving demand for additional prescription and over-the-counter drugs.
The US Food and Drug Administration has unleashed a potentially prolific source of hydroxychloroquine sulfate tablets, under investigation for efficacy against the COVID-19 coronavirus, by adding the approved malaria, lupus and rheumatoid arthritis treatment on 25 March to the list of drugs that outsourcing facilities regulated under Section 503B of the Food, Drug and Cosmetic Act are allowed to compound from bulk ingredients.
In the meantime, the Alliance for Pharmacy Compounders urged the FDA to place more prescription and over-the-counter drugs on the list of drugs that can be bulk-compounded due to rising demand for COVID-19 treatments.
These actions are to address a shortage of this drug and unmet need for these drugs in treating COVID-19.
The agency announced that “there are currently no FDA approved therapeutics or drugs to treat, cure, or prevent COVID-19; however, there are FDA-approved treatments that may help ease the symptoms of COVID-19. Additionally, state-licensed pharmacies and federal facilities that compound drugs under section 503A of the FD&C Act may compound drugs using hydroxychloroquine sulfate or chloroquine phosphate bulk drug substances because they are components of an FDA-approved drug, provide other requirements in the Act are met.”
The action was prompted by increasing demand for a potential treatment for the coronavirus. Such demand could allow Bayer to obtain a rarely granted emergency use authorization for the FDA. (Also see "As Chloroquine Demand Surges, Bayer Looks To Emergency Use Authorization To Enter US Market" - Pink Sheet, 23 Mar, 2020.) Chloroquine phosphate and hydrochloroquine are old anti-malaria drugs that are being tested in the US and other countries as potential treatments for coronavirus after some reports suggest patients may improve.
President Trump recently promoted the off-label use of chloroquine and hydroxychloroquine as potential COVID-19 treatments. (Also see "White House Hypes Chloroquine, A Drug Currently In Shortage, As Coronavirus Treatment Hope" - Pink Sheet, 19 Mar, 2020.)
The Drug Quality and Security Act of 2013 required that the FDA create a list of bulk drug substances for which there is a clinical need unmet by approved drug products. Another way for a bulk drug substance to get on this list is for it to appear on the drug shortages list at the time of compounding, distribution and dispensing.
Category 1 is for those substances that can be used in compounding where there was sufficient information for the FDA to evaluate them. Category 2 is for active ingredients that are not allowed in human compounding due to FDA concerns about patients’ safety. Category 3 is for active ingredients that cannot be used because applicants did not submit sufficient documentation for their review.
The Alliance for Pharmacy Compounding, which represents the American Pharmacists Association, the National Community Pharmacists Association and the National Alliance for State Pharmacy Association, requested the agency to allow more compounded versions of prescription and over-the-counter drugs for treating either COVID-19 or its symptoms.
In a 26 March letter to the FDA, the coalition said that “as this health crisis continues, pharmacies, wholesalers and manufacturers are experiencing or are likely to experience shortages of critical OTC and prescription drug products that are needed for patient care. Compounders stand ready to provide needed medications for COVID-19 treatment and drugs in shortage in the US as a result of this global crisis.”
The Alliance also wants the FDA to provide enforcement discretion for pharmacists to compound products that are “essentially a copy” of an FDA-approved drug that the agency identifies may be or is anticipated to be in shortage during this public health emergency.
The Alliance also said that “we anticipate potential shortages of critical OTC products used by COVID-19 patients. These products include pain relievers, zone and vitamin C supplements, cold medications and saline solutions for nebulizers, can be safely compounded by pharmacists.”
The group also anticipates potential shortages of critical FDA-approved prescription drugs, including drugs dispensed for patient-specific prescriptions, as well as those distributed to hospitals, clinics and doctors to administer to patients in a clinical setting.